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(Chest. 1999;116:1046-1062.)
© 1999 American College of Chest Physicians

Guidelines in Pulmonary Medicine*

A 25-Year Profile

Dani Hackner, MD; George Tu, MD; Scott Weingarten, MD, MPH and Zab Mohsenifar, MD, FCCP

* From the Division of Pulmonary Medicine and Critical Care Medicine (Drs. Hackner, Tu, and Mohsenifar), and Health Services Research (Zynx) (Dr. Weingarten), Department of Medicine, Cedars-Sinai Medical Center, University of Los Angeles California, Los Angeles, CA.

Correspondence to: Zab Mohsenifar, MD, FCCP, Room 6732, Cedars-Sinai Medical Center, 8700 Beverly Blvd, Los Angeles, CA 90048


    Abstract
 TOP
 Abstract
 Introduction
 Goals and Objectives
 Materials and Methods
 Results
 Discussion and Analysis
 Conclusion
 References
 
Objective: We attempted to identify clinical practice guideline and pathway articles in the area of pulmonary medicine published in peer-reviewed journals since 1974.

Design: Review.

Data sources: MEDLINE, the Cochrane Database, Best Evidence, and Abstracts of Clinical Care Guidelines from January 1974 to December 1998.

Study selection: All articles contained relevant search terms for pulmonary topics and were included irrespective of setting (primary or specialty, inpatient or outpatient). Controlled and uncontrolled trials as well as observational studies and consensus opinion/statements were all identified. The articles were stratified by design as well as by pulmonary topic.

Data extraction: Limited data on study type, study focus, year of publication, and results of study were abstracted.

Results: Our criteria yielded 271 articles, including 115 consensus statements and expert opinion guidelines; 30 controlled studies, meta-analyses, or systematic reviews; and 126 uncontrolled trials and observational studies. Of these, 82 articles (30.3%) related to asthma, 46 articles (17.0%) related to COPD, and 36 articles (13.3%) related to pneumonia. In addition, we tracked the increasing publication of all guideline-related pulmonary articles; randomized, controlled trials (RCTs); systematic reviews; and consensus statements by year for the past 25 years.

Conclusion: Pulmonary guidelines are increasingly published in peer-reviewed journals, but few are tested clinically in RCTs. There is continued reliance on consensus statements and expert opinion. Pulmonary guideline publications have continued to dramatically increase in number and in importance since 1974, both on the local level and internationally.

Key Words: asthma • COPD • emphysema • evidence-based medicine • pneumonia • practice guideline • pulmonary • review • trends


    Introduction
 TOP
 Abstract
 Introduction
 Goals and Objectives
 Materials and Methods
 Results
 Discussion and Analysis
 Conclusion
 References
 
Clinical practice guidelines have emerged in large numbers in pulmonary medicine in the past 25 years. These are statements and protocols for providers (and in some cases patients) that guide care in specific areas of medicine. Possible contributing factors include increased managed-care penetration, emphasis on cost-efficient care, attempts to develop evidence-based medicine, concern about medico-legal standards, and quality improvement processes. Do these "clinical practice guidelines" represent a passing wave in pulmonary medicine? Do guidelines represent a strong current of evidence-based clinical practice? To date, no overview of the progress in guideline development or a description of the types of guidelines exist in the peer-reviewed pulmonary literature.

With respect to pulmonary disease, clinical practice guidelines raise certain questions. What kinds of guideline-related articles appear in the peer-reviewed literature? Can one identify important consensus-based or expert opinion national guidelines in pulmonary medicine? To what degree do we rely on published consensus statements vs rigorous studies? Can one locate key randomized, controlled studies of guidelines?

Guidelines also raise other questions relevant to medicine generally. What is the role of nationally developed and consensus-based statements in relation to local practice and local research? Can locally developed or studied guidelines be applied at other sites or even nationally? What is the relative contribution of rigorous randomized, controlled trials (RCTs) of guidelines and smaller, interventional studies? Do published guidelines represent the guidelines applied in clinical practice, or does the literature miss many guidelines?


    Goals and Objectives
 TOP
 Abstract
 Introduction
 Goals and Objectives
 Materials and Methods
 Results
 Discussion and Analysis
 Conclusion
 References
 
We undertook a chronological review of pulmonary medicine guidelines over the past 25 years, with the primary aim of quantifying the numbers and types of clinical practice guideline-related publications in the peer-reviewed pulmonary literature. We also focused on guidelines in three key pulmonary areas: asthma, COPD, and pneumonia. Finally, we discuss the trends in publication of pulmonary practice guidelines.


    Materials and Methods
 TOP
 Abstract
 Introduction
 Goals and Objectives
 Materials and Methods
 Results
 Discussion and Analysis
 Conclusion
 References
 
Data Sources
In order to identify clinical practice guideline and pathway articles in pulmonary medicine published in peer-reviewed journals since 1974, we searched several Ovid databases for articles. MEDLINE (from 1974 to the second week of December 1998), Best Evidence, and the Cochrane Library were selected. In addition, we individually reviewed several core journals (CHEST, American Journal of Respiratory and Critical Care Medicine, Lancet, BMJ, New England Journal of Medicine, Annals of Internal Medicine, and JAMA [Journal of the American Medical Association]) using the specific search terms (see below). We also reviewed bibliographies of systematic reviews and randomized, controlled studies for other articles. Finally, we reviewed all issues of Abstracts of Clinical Care Guidelines from 1989 to 1998 for any missed articles. With this strategy, we attempted to be particularly thorough in three key areas: pneumonia, asthma, and COPD/emphysema. EMBASE was not included.

Search Terms
Pulmonary articles were selected by these terms: lung*, lung (MeSH), lung diseases (MeSH), lung diseases–obstructive (MeSH), lung neoplasms (MeSH), lung transplantation (MeSH), lung volume measurements (MeSH), pulm*, asthma (MeSH), tuberculosis (TB)–pulmonary (MeSH), pneumo*, pneumonia (MeSH), respir*, respiration (MeSH), COPD*, COAD*, chronic bronchitis*, emphysema*, pulmonary emphysema (MeSH), or emphysema (MeSH). Guideline or pathway topics were selected by these terms: guideline*, practice guidelines (MeSH), critical pathways (MeSH), critical pathway* or clinical pathway*. Articles found in both pulmonary AND guideline/pathway sets were selected. These studies were limited to human adults >= 18 years old.

Review Strategy
The aim of this strategy was to broadly categorize any relevant pulmonary guideline/pathway-related publications, not to detail the methodological strength of these articles. Two independent reviewers read and scored abstracts for all of the studies that were included. For abstracts without stated methodologies, the full-text articles, published topic reviews, and specific article reviews were obtained and scored. For controlled studies, all full-text articles were reviewed and scored. Concealment was not a criterion for review. Studies of the elements of published guidelines as well as studies of entire guidelines were included. The reviewers met to resolve differences in perceived article methodology, topic area, or relevance.

The reviewers encountered one class of articles calling for future guidelines, and these were excluded. Together with other articles meeting our inclusion criteria, these are collectively termed "possibly pulmonary guideline-related articles" in this review. Other articles excluded were those referring to or studying air quality guidelines. Articles investigating a specific aspect of an established guideline were included; however, nonsystematic reviews of an established guideline were excluded unless a new guideline was introduced. Also included were guidelines for a specific drug or oxygen prescription regimen for a pulmonary condition. Finally, articles that used guideline compliance as a secondary outcome were included.

Article Classification
The articles were identified first by the presence of a control group and a randomization scheme. Interventional trials without control subjects were separately identified. Uncontrolled studies in which no intervention was made were marked as observational. Consensus statements from societies or government agencies were earmarked. Statements from a group of authors were categorized as expert opinion, but were grouped along with consensus statements. The study focus area was limited to asthma, COPD/emphysema, pneumonia (nosocomial or community-acquired), or other. The year of publication since 1974 was used to group the studies into 5-year categories, ending with the period from 1994 to 1998 (Fig 1 ).



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Figure 1. Pulmonary guideline-related articles in selected subject areas.

 

    Results
 TOP
 Abstract
 Introduction
 Goals and Objectives
 Materials and Methods
 Results
 Discussion and Analysis
 Conclusion
 References
 
We obtained 1,582 articles using the search terms provided above. After limiting the articles to those with human participants >= 18 years old, the list contained 593 articles. After a review of the articles, 271 were selected that contained practice guidelines (with or without pathways) or studies of guidelines. Tables 1 2 3 summarize the numbers of studies published every 5 years for the past 25 years by publication type (study design) and by pulmonary area. By pulmonary topic, 82 (30.26%) were asthma articles, 46 (16.97%) were COPD articles, and 36 (13.28%) were pneumonia articles. The remaining 107 of 269 articles (40.07%) covered diverse pulmonary topics.


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Table 1. Guideline-Related Articles by Subject Area and Year

 

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Table 2. Guideline-Related Articles by Study Design and Year*

 

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Table 3. Pulmonary Guideline-Related Articles by Publication Type and Topic*

 
One hundred fifteen consensus statements and expert opinion publications provided guidelines for clinical practice. Tables 4 5 6 7 provide the consensus statements and expert opinion by pulmonary area. Twenty-four (20.9%) were asthma related, 17 (14.8%) were COPD related, and 12 (10.4%) were pneumonia related. In other pulmonary areas, 62 guideline consensus statements were identified (53.9%). From 1994 to 1998, the number of all consensus-based or expert opinion guidelines varied from 13 (in 1995) to 20 (in 1996). Of interest, only 5 were identified in 1998, a decrease from 17 the previous year. No decline in studies, randomized or not, was observed for 1998.


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Table 4. Asthma Consensus Statements and Expert Opinion Guidelines*

 

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Table 5. Pneumonia Consensus Statements and Expert Opinion Guidelines*

 

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Table 6. COPD Consensus Statements and Expert Opinion Guidelines*

 

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Table 7. Other Consensus Statements and Expert Opinion Guidelines*

 
Table 8 lists 30 controlled trials (all were randomized except 1 alternating month, controlled trial), as well as systematic reviews. All of the articles reported studies or systematic reviews of portions of published practice guidelines or a new guideline. Only five studies (16.7%) involve a complete practice guideline. Thirteen of 30 studies (43.3%) were asthma related, 1 (3.3%) was COPD related, 2 (6.7%) were pneumonia related, and 13 (46.7%) related to other pulmonary topics. Of note, 11 of these rigorous studies (36.7%) were published in 1998.


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Table 8. Guideline-Related RCTs and meta-analyses*

 
One hundred twenty-six studies without a randomization scheme (or without control subjects) were identified. Designs ranged from longitudinal studies, to cross-sectional studies, to prospective interventional studies, to retrospective analyses. By pulmonary topic, 45 studies (35.7%) were asthma related, 28 (22.2%) were COPD related, and 22 (17.5%) were pneumonia related. Thirty-one of 126 studies identified (24.6%) related to other topics. Forty-four of 126 studies (34.9%) studied areas related to guideline compliance, either using compliance as a primary or secondary outcome of the study, or evaluating causes for guideline compliance (or noncompliance).


    Discussion and Analysis
 TOP
 Abstract
 Introduction
 Goals and Objectives
 Materials and Methods
 Results
 Discussion and Analysis
 Conclusion
 References
 
Consensus Statements
One hundred fifteen consensus statements or expert opinions recommended specific guidelines for clinical practice (Table 4) . This group also included some dose guidelines (eg, theophylline) or test interpretation guidelines (eg, pulmonary function study interpretation). Among the first of the consensus-based guidelines, a guideline for asthma exercise challenge tests by Eggleston et al14 was published for the American Academy of Allergy. Subsequently, an oxygen therapy guideline was proposed by Mak et al47 in 1980. In the years from 1984 to 1988, 11 new consensus statements and expert opinion guidelines in areas such as emergency treatment of asthma, use of BAL, COPD, out-of-hospital ventilation, TB and nontuberculous mycoses, and pneumocystis prophylaxis. In the next 5 years, from 1989 to 1993, 33 consensus statements and expert opinion guidelines in areas similar to the prior years were reported in the literature, as well as additional examples related to community-acquired pneumonia, pneumocystis, and withdrawal of life-sustaining therapy. Finally, 1994 to 1998 has been a rich period for national guideline development in TB, sleep apnea, asthma, smoking prevention and treatment, noninvasive ventilation, community-acquired pneumonia, COPD and lung volume reduction, acute lung injury, and lung transplantation. This period accounts for 68 consensus statements and expert opinion-based practice guidelines, 59% of the total for the past 25 years. Likely, this figure misses many guidelines that are presented within published studies; however, an even higher percentage of studies over the past 25 years, 71% of nonrandomized studies and 80% of randomized trials (or systematic reviews), occurred in the only the past 5 years (Table 1) . Most importantly, consensus statements and expert opinion continue to hold a prominent place in the pulmonary guideline literature (Fig 2 ).



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Figure 2. Guidelines proposed and studied in the pulmonary literature.

 
RCTs
We located 30 prospective, controlled studies, meta-analyses, and systematic reviews of pulmonary guidelines in the literature since 1974. Prior to 1982, we did not identify RCTs or systematic reviews. The first we identified, a study by McConnell et al,133 studied upper respiratory infections. The earliest relevant meta-analysis by Tryba141 assessed stress ulcer prophylaxis and its impact on nosocomial pneumonia outcomes. Several other stress ulcer prophylaxis studies, including the 1993 study by Fabian et al,123 have debated the impact on pneumonia with various gastric pH modifying agents. 1993 was also an important year for asthma education, heparin nomogram development, and literature emphasizing rigorous guideline assessment.128 Again, the most recent 5 years accounted for 80% (24/30) of the systematic reviews, meta-analyses, and RCTs identified over the past 25 years. In addition, during 1998 alone 46% (11/24) of the RCTs from the past 5 years have been published. In short, there appears to be a widespread increase in the published guideline literature, whether opinion-based or rigorous studies. Still, in comparison with the entire list of publications of practice guidelines, publications of RCTs still appear to be few in number (Fig 2) .

Important Guideline Articles in Asthma, COPD, and Pneumonia
While there has been a general steep rise in guideline-related pulmonary publications in the past 2 decades, has the rise been uniform across pulmonary subject areas? We evaluated the trends in guideline-related articles in three key pulmonary areas: asthma, COPD, and pneumonia, both community-acquired and nosocomial bacterial pneumonia (Fig 2) . In an effort to be especially thorough in these areas, we included an expanded list of search terms. Similar to the trend of increasing consensus statements and studies, in each of the three selected pulmonary topics, there has been a steady rise in published guideline-related publications. In addition, we created a category excluding asthma, COPD, and pneumonia studies, and still found a consistent rise in the past 2 decades.

Asthma
In the area of asthma, guideline articles have increased dramatically, with a progression from consensus statements and small studies to randomized, controlled studies and systematic reviews. Especially notable are the early papers in asthma that date to 1974; each 5-year period, publications have more than doubled in number. Since 1992, national asthma guidelines have been developed in at least four continents.4 9 10 11 20 23 In turn, there have been numerous studies documenting guideline noncompliance in asthma as well as validating metered-dose inhaler guidelines.127 From 1994 to 1998, there have been important randomized trials by Bernstein et al,118 by van der Molen et al,142 and the Grampian Asthma Study of Integrated Care group.126 Finally, in 1998, important systematic reviews by the Cochrane Collaboration evaluated ß-agonist devices, patient education, and homeopathy in asthma.19 120 125 131 Examples of findings include that guidelines disseminated with practice-based education may improve asthma management in inner cities and possibly allow cost savings in chronic disease management. They also found that structured consultation recommended by the guidelines improved compliance.125

In addition to increasing rigorous, controlled studies in the asthma literature, dissemination and study of guidelines appears to be leading to change in practice. In asthma, national consensus statements may play a crucial role. Spelman146 studied how the implementation of British Thoracic Society (BTS) asthma guidelines resulted in a substantial change in local bronchodilator use. These national consensus statements may serve as public domain guidelines and may establish standards of care for a region. In addition, they may spur the development of locally tailored practice guidelines. After the adoption of locally developed guidelines in East London, quality of prescribing improved.124 Similar results have been observed in Saskatchewan after local implementation of national guidelines.147 In short, guideline dissemination may be affecting local practice patterns as well as stimulating local guideline development.

In the area of asthma, local studies of practice guideline may validate or place in question an element of national guidelines. Bernstein et al148 tested the safety and outcomes of inhaled corticosteroid treatment in mild-to-moderate asthma, consistent with the recommendations of the National Institutes of Health (NIH) guideline. On the other hand, Haahtela et al149 have reported clinical benefits with a treatment not in the current NIH asthma guideline: inhaled corticosteroid treatment for mild asthma. Their study suggested a program of long-term therapy of mild asthma aimed at reducing inflammation with inhaled steroids. Maintenance doses were lower than quantities reported to initially normalize lung function and appeared to show long-term disease stabilization. The authors recommend validation of their findings in a clinical practice setting. These asthma studies suggest a pattern for guideline-based quality improvement, beginning with an expert opinion practice guideline, leading to studies that challenge or validate elements of the guideline, and finally resulting in trials of new practice guidelines.

Pneumonia
In pneumonia, the guideline literature has developed recently. Eighty-nine percent of pneumonia-related publications have occurred in the past 5 years (Table 3) . Two paths have emerged recently in the literature, one starting with consensus statements and the other beginning with early evidence-based approaches. Along the first path, the American Thoracic Society (ATS) published a community-acquired pneumonia guideline in 1993.29 The guideline was based on an empiric strategy, in large part to the paucity of prior research and clinical information available. Subsequently, the ATS approach has been validated in part by Gordon et al150 in 1996. Similarly, the BTS guidelines have been studied by Neill et al.151 In addition, several other studies have evaluated various aspects of these national pneumonia guidelines from infectious etiologies to local compliance.28 29 30 Internationally, the 1993 ATS guideline, along with the Canadian-published guideline by Mandell and Niederman,35 has paved the way for several other countries, including the Italian guidelines in 1995, South African in 1996, and Dutch in 1997 and 1998.25 33 34 35 36

A second path in the area of pneumonia was paved by evidence-based studies. Notable pneumonia guideline studies by Weingarten et al144 in 1994, Leroy et al152 in 1996, and Fine et al153 in 1997 have originated low-risk criteria or prognostic scores for pneumonia. These focused prognostic and diagnostic tools may be amenable to large studies, and they may be portable from center to center. As national guidelines are revised, the incorporation of key elements such as a risk stratification tool may be effective. Another evidence-based highlight is the systematic review by Cook et al121 on nosocomial pneumonia ventilator management in 1998. In summary, in the area of pneumonia, there have been two productive paths: one with evidence-based, outcomes-oriented local studies and a second with consensus-based national guidelines. Both have led to validated approaches to pneumonia care.

COPD
Also recently, COPD studies have emerged in the literature (Table 5) . Seventy percent of COPD studies we identified occurred in only the past 5 years. In 1996, several important COPD guideline-related reports were published (Table 6) . Following on the heels of earlier COPD guidelines by the Canadian Thoracic Society39 and the European Respiratory Society study on COPD,48 Siafakas et al50 in Europe and Celli38 in the United States published their national guidelines. In addition, in 1996, guidelines for lung volume reduction surgery (LVRS) were published by Criner et al,42 by Holohan,46 and by Yusen and Lefrak.53 Subsequently, due to the paucity of rigorous, controlled outcomes studies in the area of LVRS for COPD, the guidelines for lung volume reduction have been formulated into the National Emphysema Treatment Trial (NETT). The NETT randomizes Medicare patients to LVRS following rehabilitation or to rehabilitation alone. In addition to physiologic outcomes such as pulmonary function and exercise testing, health-related quality of life are being be assessed.154 The NETT study marks an important intersection between national guidelines and outcomes studies. Large studies of its kind may represent a move toward national managed care of costly but unproven therapies. In contrast to private payor-driven guidelines, its results will be public and subject to peer review.

Questions Raised About Guidelines and Outcomes Studies
Large outcomes studies such as the NETT raise important questions. First, what is the difference between clinical practice guidelines with careful monitoring of outcomes and carefully designed outcomes studies? One important distinction is between study designs that integrate explicit practice guidelines and designs that address guideline-related issues, such as metered-dose inhaler recommendations from asthma guidelines. Our review does not attempt to separate the two; in the area of RCTs, there are even fewer explicit trials of complete guidelines compared to the large number of studies that evaluate portions of consensus guidelines. Large trials such as the NETT study also include repeated measures that would not likely be part of a practice guideline due to expense. An economic analysis of the cost-effectiveness of large RCTs vs observational studies may help design affordable implementation and validation strategies. An analysis may also be needed to assess the most cost-effective means to monitor long-term outcomes and ongoing compliance.

Large guideline trials and outcomes studies like the NETT have raised ethical questions as well. The NETT requires participation in the study for Medicare funding of lung volume reduction. In a sense, it functions as an approved national guideline. What is the impact of linking insurance payments to (experimental) guideline compliance with respect to patient autonomy, confidentiality, and distributive justice? After extensive review by ethics panels, the NETT was approved. Still, in the future these concerns will continue to surface as guideline outcomes data are aggregated on national guidelines.

Aside from large trials, how common do guidelines evolve from a systematic, evidence-based approach? Naylor et al155 reviewed strategies for guideline development and research promotion. Using the example of pulmonary artery (PA) catheterization, they found only six randomized, controlled studies of PA catheterization guidelines or protocols. None of the published guidelines used a formal group process together with a hierarchical review of evidence to develop PA catheter indications. To date, no in-depth data exist on the fraction of guidelines that are evidence-based in the pulmonary literature.

Questions Raised About Unpublished Guidelines
Peer-reviewed studies and statements may only be the tip of a large unpublished guidelines and pathways iceberg. In our center, there are at least 59 guidelines and pathways in medicine, surgery, pediatrics, obstetrics/gynecology, and psychiatry. Of the 17 medicine guidelines, only 5 have been published and only 2 of these are pulmonary related.

In a competitive market environment, health systems may have financial incentives to develop guidelines. Especially in markets with high managed-care penetration, guidelines may be an economic imperative for the survival of a health-care system. One guideline illustrates how limited outcomes may have a significant financial impact on the medical center. Bailey et al156 studied the acute exacerbation of asthma in adults, validating it in a retrospective study of 42 patients. Nineteen patients were enrolled in the pathway over a 6-month period in 1995. Thirty-eight similar patients from 1994 were historical controls. A significant increase in conversion from hand-held nebulizer to metered-dose inhaler was observed: 68% vs 34% (p < 0.05) comparing to the nonpathway group, and 68% vs 26% (p = 0.002) comparing to the 1994 historical control group, resulting in a significant cost savings of $288,000 per year.

Despite the economic imperative to develop competitive guidelines, some health systems may have no incentive to publish the guidelines. In addition to potentially giving a financial boost to a rival system, a guideline could incur liability for those who develop guidelines. Hyams et al157 raised questions about how guidelines have been used in the "two-way street" of the courts, in which plaintiffs may have more frequently used guidelines, although the interpretation of their data has been disputed.158 On the other hand, Noble et al159 have also highlighted a case of medical negligence due to the failure to adopt guidelines in a blood bank.

Other factors possibly impeding guideline dissemination include publication bias and the cost of performing clinical studies. Negative outcomes studies may be seen as adverse publicity for a quality improvement "failure." Academic factors in particular may favor studies of practice guidelines. The indirect benefits of publication may not be incentive enough for nonacademic centers to publish. Even at academic centers, the sharing of medical developments may be minimized by increasing clinical workloads; physicians may not be able to justify spending time on unreimbursed activities such as conference participation and guideline publication.

Toward Improving the Guideline Process: Funding, Oversight, and Appropriate Applications
One potential solution, the additional funding of guideline research and development, may reward those who publish. Unfortunately, simply funding more guideline development may not reward successful guidelines or competitive guidelines. Moreover, participants in guideline development may have competing motivations. Some systems may simply wish to minimize costs without necessarily improving quality. Others, such as medical societies or provider groups (such as advanced practice nurses and pharmacists) may be eager to promote a certain provider's involvement or increase referrals. Advocates may promote a particular model of care, such as "disease management," "primary care," or the "hospitalist" model. Health systems that are heavily invested in certain services, procedures, devices, or drugs may develop guidelines to enhance their utilization. Poor guideline development could be costly and counterproductive in global health-care budgets.

The oversight of guidelines by government or private agencies could improve accountability in the design of guidelines. It could also lead to the wider publication of guideline experience. Examples of agencies that promoted guideline development include the Joint Commission on Accreditation of Healthcare Organizations, the National Committee for Quality Assurance, and the American Medical Accreditation Program, with their collaborative Performance Measurement Coordinating Council.160 Other examples include the efforts of the Agency for Health Care Policy and Research (AHCPR) to fund and influence performance through evidence-based medicine. Notable AHCPR products include the guidelines on smoking cessation and the cost-effectiveness study of cessation guidelines that revealed favorable findings of low cost per quality-adjusted life year saved.55 161 Possible hazards of a centralized or government approach include overregulation, slowed guideline development, and further increased costs. For instance, in the area of infection control, efforts led by the Joint Commission on Accreditation of Healthcare Organizations have been linked to new hospital expenditures on new practice guidelines, but we still lack data that quality of health care has been improved.162 Some important areas for future research include economic analyses of the impact of guidelines on large health systems, their patients, and their providers.

Can a locally-developed guideline be applied to another site or even adopted nationally? Guidelines originating in one locale may have markedly different outcomes at other centers due to regional or institutional factors.163 In some areas, nationally disseminated guidelines may not necessarily improve care, as Weingarten164 has pointed out. But without publication of local experience, guideline failures (and successes) may go unnoticed; health systems involved in new guideline development may be forced to repeat others' mistakes or to reinvent the wheel. Cross-sectional studies of geographic variability in guideline content and compliance may be needed to identify regions with implementation success and those needing new approaches.

To answer how published guidelines relate to current practice, a large, questionnaire-based study would be needed. A similar study would be needed to address the relationship between unpublished and published guidelines. Furthermore, longitudinal studies may be needed to link practice guidelines with the improvement of ongoing clinical processes and outcomes.17 Such studies may address the important relationship between "community standard" of care and "evidence-based" care, as well as the issue of compliance.

Limitations of This Review
This review attempted to identify pulmonary-related practice guidelines and studies of those guidelines in the peer-reviewed literature using an explicitly stated review strategy. By including prior versions of guidelines, we avoided a natural bias to more recently published reports. By using keyword as well as MeSH terms (some of which did not exist years ago), we also hoped to avoid bias toward recent reports. Although we minimized some of that bias, we still are limited by the term "guideline" itself, and synonyms may have appeared in the earlier literature (recommendations, protocols, procedures, outlines, flow-charts, and others). This bias may have been minimized by using other references such as Abstracts of Clinical Care Guidelines, from early 1989 (which identifies earlier guidelines), but these other references carry their own biases.

Some of the publications are strictly-speaking, not peer-reviewed, but are official publications of national organizations, such as the NIH. These too were referenced by some of the included articles and guideline abstracts, and we believed they were important to include. We also included articles that incorporated clinical pathways as well as guidelines, but we did not review pathways alone in any detail. As discussed, the list of randomized, controlled studies of guideline-related issues includes few studies of entire guidelines. This illustrates the paucity of rigorous, controlled guideline studies. Most of all, this study does not detail specific subject areas that deserve separate systematic review, meta-analysis, or overview.


    Conclusion
 TOP
 Abstract
 Introduction
 Goals and Objectives
 Materials and Methods
 Results
 Discussion and Analysis
 Conclusion
 References
 
Pulmonary guidelines are increasingly published in peer-reviewed journals over the past 25 years. We can identify important consensus-based or expert opinion national guidelines in pulmonary medicine. We can also locate rigorous, controlled studies and meta-analyses of practice guidelines. Likewise, we have found many studies of key portions of published national guidelines and consensus statements. These rigorous studies and reviews are increasing, as well as small, nonrandomized studies. However, 1998 has seen a decrease in consensus-based and expert opinion guidelines. Despite the decrease in published consensus-based guidelines in 1998, all trials of pulmonary guidelines continued to increase in the past year. In all, clinical practice guidelines do not appear to be a passing wave in pulmonary medicine.

Do guidelines represent a strong current of evidence-based clinical practice? In general, few guidelines have been tested clinically in RCTs or are subject to systematic review. In areas such as COPD, pneumonia, and asthma, where national guidelines have been disseminated, multiple uncontrolled clinical studies relating to the guidelines have been published and in some cases serve to modify national guidelines. In addition, controlled studies of portions of these guidelines are appearing in the literature. In addition, though national consensus statements are no replacement for large RCTs (and can potentially interfere with RCTs), they may lead to large and potentially useful administrative data collections.

National guidelines may lead to both local and international guideline development. As costly choices may be faced on the national level, national guidelines may be mandatory for certain federally funded procedures or treatments. In certain areas such as pneumonia, rather than attempting a full-scale adoption of locally developed guidelines, key portions of guidelines, validated in outcomes studies, may make their way into national guidelines. But where local guidelines only serve as proprietary, internal health system protocols, their merits or failures will likely be missed in the published, peer-reviewed literature.

Finally, there are several factors that may impede guideline dissemination and study, from publication bias and legal issues to cost and competition. Yet despite any disincentive to publish, pulmonary guideline publications have continued to dramatically increase in number and in importance on the local and the international level.

A more comprehensive study of pulmonary guidelines is needed. It should survey health systems and experts in pulmonary medicine or guideline development. Such a study would assist in tracking guidelines and locating important studies. The ability to track the numbers and types of practice guidelines may eliminate redundant efforts and may locate areas needing additional practice guideline development. In addition, a comprehensive guideline study may identify unpublished practice guidelines and published guidelines that are changing community standards of care.


    Footnotes
 
Abbreviations: AHCPR = Agency for Health Care Policy and Research; ATS = American Thoracic Society; BTS = British Thoracic Society; LVRS = lung volume reduction surgery; NETT = National Emphysema Treatment Trial; NIH = National Institutes of Health; PA = pulmonary artery; RCT = randomized, controlled trial

Received for publication March 1, 1999. Accepted for publication May 12, 1999.


    References
 TOP
 Abstract
 Introduction
 Goals and Objectives
 Materials and Methods
 Results
 Discussion and Analysis
 Conclusion
 References
 

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